BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ COLONIC

    MDR report key: 2890436 · Received December 30, 2012

    Report

    Report Number
    3005099803-2012-06227
    Event Type
    Malfunction
    Date Received
    December 30, 2012
    Date of Event
    September 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MQR
    PMA / PMN Number
    K061877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS UNKNOWN; HOWEVER, REPORTED TO BE OVER 18 YEARS OLD. (B)(4) FOR THE EVALUATION FINDINGS OF POLYTETRAFLUOROETHYLENE (PTFE) COATING DELAMINATION FROM CATHETER. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE OUTER SHEATH WAS RETRACTED 210MM FROM THE TIP AND THE STENT HAD BEEN FULLY DEPLOYED FROM THE DEVICE. THE STENT WAS NOT RETURNED FOR ANALYSIS. IT WAS NOTED THAT THE DISTAL HANDLE WAS DETACHED FROM THE OUTER SHEATH. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE SHAFT. NO OTHER ISSUES WERE NOTED WITH THE PROFILE OF THE DEVICE. DURING ANALYSIS, IT WAS POSSIBLE TO MOVE THE OUTER SHEATH ALONG THE SHAFT WITHOUT ANY ISSUES BEING NOTED. THE SHAFT WAS DISSECTED AT THE PROXIMAL END OF THE CLEAR OUTER SHEATH AND THE DISTAL END OF THE INNER LUMEN AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. NO ISSUES WERE NOTED WITH THE PROFILE OF THE INNER LUMEN THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT REPORTED. THE OUTER SHEATH WAS DISSECTED LONGITUDINALLY AND IT WAS NOTED THAT SOME OF THE POLYTETRAFLUOROETHYLENE (PTFE) COATING HAD DETACHED FROM THE INSIDE OF THE OUTER SHEATH. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL COLONIC STENT DEVICE WAS USED DURING A COLON STENTING PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENT WAS PALLIATIVE TREATMENT OF A MALIGNANT STRICTURE WITHIN THE SIGMOID COLON. IT WAS REPORTED THAT THE STRICTURE WAS NOT "TIGHT". THE DEVICE WAS USED IN CONJUNCTION WITH A JAGWIRE 0.035INCH. DURING THE PROCEDURE, WHEN IT WAS ATTEMPTED TO RELEASE THE STENT, RESISTANCE WAS MET AND THE STENT WAS DIFFICULT TO DEPLOY. WHEN THE STENT WAS 90% DEPLOYED, THE DISTAL HANDLE DETACHED FROM THE OUTER SHEATH. REPORTEDLY, THE PHYSICIAN THEN MANUALLY RETRACTED THE OUTER SHEATH TO DEPLOY THE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH FOUND PART OF THE POLYTETRAFLUOROETHYLENE (PTFE) COATING HAD DETACHED FROM THE INSIDE OF THE OUTER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX¿ COLONIC STENT, COLONIC, METALIC, EXPANDABLE MQR BOSTON SCIENTIFIC - GALWAY M00565120 15077019

    Patients

    Seq Age Sex Outcome Treatment
    1